RSV F protein

PHILADELPHIA, PA, USA I September 18, 2024 I GSK plc (LSE/NYSE: GSK) today announced positive topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) when co-administered with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), both AS01-adjuvanted vaccines (NCT05966090). 1,2 The data were presented as a late-breaking abstract at the European Geriatric Medicine Society (EuGMS) Congress in Valencia, Spain (September 18-20th, 2024). 2 SHINGRIX is approved for the prevention of shingles (herpes zoster) in adults aged 50 years and older. AREXVY is approved for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. The data showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits. 2 Co-administration was also well tolerated, with acceptable reactogenicity and safety profiles. 2 In both groups, the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia. 2 The duration of solicited adverse events was comparable across the two groups. 2 Len Friedland, MD, Vice President of Scientific Affairs and Public Health, GSK, said: “We are excited to share data on the co‑administration of our RSV and shingles vaccines. Adult immunization offers immense individual and societal benefits and yet, vaccination rates for adults are often inadequate. With our co-administration studies, GSK is using its science and technology to help remove barriers to adult immunization, by potentially reducing the number of visits to the healthcare offices and pharmacies and ultimately help to get ahead of RSV and shingles.” Results from this trial will be submitted for peer-reviewed scientific publication and will be used to support regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulators. Both RSV and shingles pose significant health risks to older adults, and these risks only increase with age as the immune system declines. Immunocompromised individuals and those with certain underlying medical conditions—for example, asthma and COPD—may also be at increased risk for these diseases. 3,4,5 RSV is a common, contagious respiratory virus that can lead to potentially serious respiratory illness. 3 Each year, approximately 177,000 adults 65 years and older are hospitalized in the US due to RSV and an estimated 14,000 of those cases result in death. 6 Shingles is a painful, blistering rash that can last for weeks. Because it is caused by the reactivation of the varicella zoster virus (VZV)—the same virus that causes chickenpox—99% of US adults have the virus that causes shingles inside their body, although not everyone will develop shingles. 7 An estimated one million people develop shingles annually in the US. 8 About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant. The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 50 countries, including Europe, Japan and US. It is also approved in several countries for use in adults aged 50–59 at increased risk for RSV-LRTD, including European Union/European Economic Area and US. Regulatory reviews in multiple countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets. The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. Indication for AREXVY AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: Important Safety Information for AREXVY Please see full Prescribing Information for AREXVY. About SHINGRIX(Recombinant Zoster Vaccine or RZV) SHINGRIX is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over. It combines an antigen, glycoprotein E, with an adjuvant system, AS01 B , and may help overcome the natural age-related decline in responses to immunization that contributes to the challenge of protecting adults aged 50 and over from shingles. 9,10 RZV is not indicated to prevent primary varicella infection (chickenpox). In several countries, it is also approved for adults aged 18 years or over at increased risk for shingles. The use of RZV should be in accordance with official recommendations and local product label. Indication for SHINGRIX SHINGRIX is an FDA-approved vaccine for the prevention of shingles (herpes zoster) in: SHINGRIX is not used to prevent chickenpox. Important Safety Information for SHINGRIX Please see full Prescribing Information for SHINGRIX. About the NCT05966090 trial The co-administration study is a phase 3, open-label, multi-country study to assess non-inferiority of immune responses in co-administration of GSK’s RSV and Recombinant Zoster Vaccine (RZV) compared to separate administration in adults aged 50 and over. 2 530 participants were randomized 1:1 to receive either GSK’s Recombinant Zoster Virus vaccine first dose and GSK’s Respiratory Syncytial Virus, Adjuvanted at visit one (Co-ad), or GSK’s Recombinant Zoster Virus vaccine first dose alone at visit one (Control). The Control group received GSK’s RSV vaccine at day 31. 1,2 RZV second dose was administered at day 61 for both groups. 1,2 The primary endpoint was the non-inferiority of the humoral immune responses to GSK’s RSV vaccine and RZV when co-administered compared to when administered at separate visits. 1,2 Key secondary endpoints included reactogenicity and safety following co-administration versus sequential administration of GSK’s RSV vaccine and RZV. 1,2 Anti-gE antibody concentrations and RSV-A and RSV-B neutralization titers increased from pre- to post-vaccination and met the non-inferiority criteria in the primary endpoint for the humoral immune responses to GSK’s RSV and shingles vaccines. 2 In both groups, the duration of solicited adverse events was short and comparable, and the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia. 2 Unsolicited adverse events reporting rates were balanced between the co-administration and control groups. 2 About RSV in Adults RSV is a common, contagious respiratory virus affecting the lungs and breathing passages. 3 Adults can be at increased risk for RSV disease due to certain underlying medical conditions, immune compromised status, or advanced age. 3 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death. 3 About Shingles Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. 11 By age 50, VZV is present in most adults 12 and may reactivate with advancing age. 13 As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles. 11 Shingles typically presents as a rash, with painful blisters across the chest, abdomen, or face. 11 The pain is often described as aching, burning, stabbing or shock-like. 14 Following the rash, a person may experience post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and occasionally persists for several years. 14 PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases from findings in various studies. 15 About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References 1. Clinicaltrials.gov, “A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults (RSV-OA=ADJ-020)”, NCT05966090 – available at: https://clinicaltrials.gov/study/NCT05966090 – Accessed in September 2024. 2. Dennis P, et al. Co-administration of the adjuvanted respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVPreF3 OA) with the adjuvanted recombinant zoster vaccine (RZV) in adults ≥50 years of age. Abstract presented at European Geriatric Medicine Society (EuGMS); 18–20 September 2024, Valencia, Spain. 3. Centers for Disease Control and Prevention (CDC), RSV in Adults. Available at: https://www.cdc.gov/rsv/older-adults/index.html . Last Accessed: September 2024. 4. Marra F, et al. Risk Factors for Herpes Zoster Infection: A Meta-Analysis. Open Forum Infect Dis 2020;7(1):ofaa005. 5. Chen S-Y, et al. Incidence of herpes zoster in patients with altered immune function. Infection. 2014; 42: 325–334 6. Falsey, AR et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59. 7. CDC. About Shingles (Herpes Zoster). Available at https://www.cdc.gov/shingles/about/index.html 8. CDC. Shingles (Herpes Zoster): Clinical Overview. Available at: https://www.cdc.gov/shingles/hcp/clinical-overview/index.html 9. Cunningham, AL, et al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. New England Journal of Medicine. 2016;375(11):1019–32. 10. The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes. 11. Harpaz R, et al. Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1–30. 12. Johnson, R.W., et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Therapeutic advances in vaccines. 2015;3(4):109–20. 13. Mueller, N.H., et al. Varicella zoster virus infection: clinical features, molecular pathogenesis of disease, and latency. Neurologic clinics. 2008;26(3):675–97. 14. Cheng J, Rosenquist RW. Herpes zoster and postherpetic neuralgia. Fundamentals of Pain Medicine . 2018:221-5. 15. Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014;4:e004833. doi: 10.1136/bmjopen-2014-004833. SOURCE: GlaxoSmithKline

NEW YORK, NY, USA I August 12, 2024 I Pfizer Inc. (NYSE: PFE) today announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial ( NCT05842967 ) MONeT (RSV I M munizati ON Study for Adul T s at Higher Risk of Severe Illness),evaluating two doses of ABRYSVO vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). Adults with immunocompromising conditions have an increased risk of developing RSV-LRTD. Substudy B of the MONeT trial was conducted to assess the safety and immunogenicity of two doses of ABRYSVO, administered one month apart, in four groups of immunocompromised adults: those with non-small cell lung cancer, those on hemodialysis due to end-stage renal disease, those with autoimmune inflammatory disorder receiving active immunomodulator therapy, and solid organ transplant recipients. Of the 203 adults enrolled in the substudy, approximately half were between the ages of 18 to 59, and approximately half were 60 years or older. ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. While the company evaluated two doses, a single 120 µg dose of ABRYSVO generated a strong neutralizing response against both subtypes of RSV, RSV-A and RSV-B, across all cohorts and age groups in the study. Pfizer plans to share these findings at an upcoming scientific conference and publish them in a peer-reviewed scientific journal, as well as submit these data to the regulatory agencies for review. “Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We are encouraged by the positive top-line data from this study, which provide important evidence that ABRYSVO has the potential to address a significant unmet need in this vulnerable population.” These most recent data in immunocompromised adults build on the body of evidence supporting the profile of ABRYSVO in high-risk adults. In June of 2024 at the meeting of the Advisory Committee on Immunization Practices ( ACIP ), Pfizer presented results from a cohort of adults aged 18-59 with certain chronic medical conditions. In the double-blinded study, 681 adults aged 18 to 59 with chronic conditions were randomized 2:1 to receive a single dose of ABRYSVO or placebo. Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO, which previously demonstrated ABRYSVO’s efficacy in a population of adults aged 60 or older. These results support previous data presented at the ACIP showing high ABRYSVO clinical effectiveness against lower respiratory tract disease among a population of adults age 60 years and older that included a substantial proportion of immunocompromised persons. Approval of ACT-O-VIAL ® Additionally and as previously announced, the U.S. Food and Drug Administration (FDA) has approved Pfizer’s supplemental Biologics License Application for the ACT-O-VIAL® presentation of ABRYSVO. This approval allows Pfizer to bring a new option to market alongside its existing needle-free reconstitution kits. The ACT-O-VIAL System is a dual-component vial system that simplifies the reconstitution of ABRYSVO within a single, compact device. Designed to support safety, workflow improvements and storage efficiency, the system offers significant storage space savings, which may be appealing to retailers during peak vaccination seasons. ABOUT MONeT MONeT (RSV I M munizati ON Study for Adul T s at Higher Risk of Severe Illness) is a Phase 3, multicenter clinical trial (NCT05842967) investigating the safety, tolerability and immunogenicity of ABRYSVO in adults at risk of RSV-associated disease, including adults with certain chronic medical conditions (substudy A) and adults who are immunocompromised (substudy B). Substudy A is a double-blinded study that randomized 681 adults aged 18 to 59 with chronic conditions, with 2:1 to receive a single dose of ABRYSVO or placebo. Substudy B is an open-label study that enrolled approximately 200 immunocompromised adults aged 18 or older, roughly half of which were aged 60 or older, who received two doses of ABRYSVO, one month apart. ABOUT RSV Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness. 1 The virus can affect the lungs and breathing passages of an infected individual and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions. 2,3,4 In the United States alone, among older adults, RSV infections account for approximately 60,000-160,000 hospitalizations and 6,000-13,000 deaths each year. 5,6,7,8,9,10,11,12,13 There are two major subgroups of RSV: RSV-A and RSV-B. Both subgroups cause disease and can co-circulate or alternate predominance from season to season. ABOUT ABRYSVO Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as infants through maternal immunization. ABRYSVO is a bivalent vaccine that was designed to provide protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer’s RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies. In May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. The Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention recommends RSV vaccines as a single dose for all adults 75 and older and for adults 60 and older at increased risk of severe RSV disease. In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. This was followed in September 2023 with ACIP’s recommendation for maternal immunization to help protect newborns from RSV seasonally where the vaccine should be administered from September through January in most of the continental United States. Also in August 2023, Pfizer announced that the European Medicines Agency (EMA) granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants. The vaccine has also received approvals from la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) of Argentina in September 2023; the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom in November 2023; Health Canada in January 2024 ; the Pharmaceutical Administration Bureau of Macau in February 2024; the Ministry of Health, Labour, and Welfare of Japan for maternal immunization to help protect infants in January 2024 and for older adults in March 2024; and the Therapeutic Goods Administration of Australia in March 2024 for older adults. In addition to MONeT, Pfizer has initiated a clinical trial evaluating ABRYSVO in children ages two to less than 18 years who are at higher risk for RSV disease. 14 INDICATIONS FOR ABRYSVO ABRYSVO ™ is a vaccine indicated in the US for: IMPORTANT SAFETY INFORMATION FOR ABRYSVO View the full ABRYSVO Prescribing Information . About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer . 1 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). https://www.cdc.gov/rsv/index.html . Updated December 18, 2020. 2 Centers for Disease Control and Prevention. How RSV Spreads. https://www.cdc.gov/rsv/causes/index.html . Updated May 30, 2024. 3 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. https://www.cdc.gov/rsv/factsheet-older-adults.pdf . Updated April 2024. 4 Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www.cdc.gov/rsv/infants-young-children/index.html . Updated June 5, 2024. 5 Centers for Disease Control and Prevention. RSV Surveillance & Research. https://www.cdc.gov/rsv/php/surveillance/ . Updated June 5, 2024. 6 Widmer K, Zhu Y, Williams JV, et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. J Infect Dis. 2012; 206(1):56-62. 7 Branche AR, Saiman L, Walsh EE, et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020. CID. 2022;74(6):1004-1011. 8 McLaughlin JM, Khan F, Begier E, et al. Rates of Medically Attended RSV among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022; 9(7): ofac300. 9 Zheng Z, Warren JL, Shapiro ED, et al. Estimated Incidence of Respiratory Hospitalizations Attributable to RSV Infections across Age and Socioeconomic Groups. Pneumonia. 2022;14(1):6. 10 Centers for Disease Control and Prevention. October 2022 ACIP Meeting Slides. ACIP Adult RSV Work Group Considerations. Available at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/12-RSV-Adult-Melgar-508.pdf 11 Thompson WW, Shay DK, Weintraub E, et al. Mortality Associated with Influenza and Respiratory Syncytial Virus in the United States. JAMA. 2003; 289(2): 179.186. 12 Matias G, Taylor R, Haguinet F, et al. Estimates of Mortality Attributable to Influenza and RSV in the United States during 1997–2009 by Influenza Type or Subtype, Age, Cause of Death, and Risk Status. Influenza Other Respir Viruses. 2014; 8(5):507-15. 13 Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 1999-2018.JAMA Network Open. 2022 Feb 1;5(2):e220527. 14 Pfizer Second-Quarter 2023 Earnings Teleconference Presentation, August 1, 2023, page, 24, https://s28.q4cdn.com/781576035/files/doc_financials/2023/q2/Q2-2023-PFE-Earnings-Release.pdf SOURCE: Pfizer

ABRYSVO met its trial primary endpoints in adults aged 18 to 59 with an increased respiratory syncytial virus (RSV) disease risk. The vaccine was well-tolerated and demonstrated an immune response non-inferior to adults aged 60 years and older Pfizer intends to submit these findings to regulatory agencies to seek approval of ABRYSVO in adults 18 to 59 years of age NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating a single dose of ABRYSVO versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). Adults with certain underlying chronic conditions are at increased risk of developing, and being hospitalized for, RSV-associated LRTD1,2. Among US adults 18 to 49 years of age, 9.5 percent have a chronic condition that puts them at risk of severe RSV disease and this percentage rises to 24.3 percent among persons 50 to 64 years of age1. However, no RSV vaccines have been approved for use in adults 18 to 59 years of age. The MONeT study was initiated to address this significant unmet need by investigating the immunogenicity and safety of ABRYSVO in adults aged 18 to 59 at increased risk for RSV disease, such as those with asthma, diabetes, and chronic obstructive pulmonary disease. The MONeT study achieved its co-primary immunogenicity endpoints and primary safety endpoint: Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated.3 Participants also achieved at least a four-fold increase in serum neutralizing titers for RSV-A and RSV-B one month following receipt of ABRYSVO compared to pre-vaccination. During the trial, ABRYSVO was well-tolerated, and safety findings were consistent with those from previous investigations of ABRYSVO in other populations. 4 Pfizer also met its diversity recruitment goals for the study providing data from participants that mirror the diverse U.S. population and had a balanced representation across underlying medical conditions. Pfizer intends to submit these data to regulatory agencies and request expansion of the age group from the current indication to 18 years of age and older. The use of immunobridging studies to extrapolate efficacy from older to younger adults is an established regulatory pathway.4 The company also intends to publish these findings in a peer-reviewed scientific journal and share them at an upcoming scientific conference. “These encouraging results provide evidence that ABRYSVO can help protect adults with increased risk against RSV-associated illness,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “We are excited to address a significant unmet need, pending regulatory authority approval, as ABRYSVO has the potential to become the first and only RSV vaccine for adults 18 years and older.” ABOUT MONeT MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness ) is a Phase 3, multicenter clinical trial (NCT05842967) investigating the safety, tolerability and immunogenicity of ABRYSVO in adults at risk of RSV-associated disease, including adults with certain chronic medical conditions (substudy A) and adults who are immunocompromised (substudy B). Substudy A is a double-blinded study that randomized 681 adults aged 18 to 59 with chronic conditions, with 2:1 to receive a single dose of ABRYSVO or placebo. Substudy B is an open-label study that enrolled approximately 200 immunocompromised adults aged 18 or older, roughly half of which were aged 60 or older, who received two doses of ABRYSVO, one month apart. ABOUT RSV Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness.5 The virus can affect the lungs and breathing passages of an infected individual and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.6,7,8 In the United States alone, among older adults, RSV infections account for approximately 60,000-160,000 hospitalizations and 6,000-13,000 deaths each year.9,10,11,12,13,14,15,16,17 RSV disease is caused by the respiratory syncytial virus. There are two major subgroups of RSV: RSV-A and RSV-B. Both subgroups cause disease and can co-circulate or alternate predominance from season to season. ABOUT ABRYSVO Pfizer currently is the only company with an RSV vaccine to help protect older adults as well as infants through maternal immunization. ABRYSVO is a bivalent vaccine that was designed to provide broad protection against all RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer’s RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies. In May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. This was followed by the ACIP’s recommendation of the vaccine for use in adults 60 years of age and older based on shared clinical decision making, which occurred in June 2023. In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. This was followed in September 2023 with ACIP’s recommendation for maternal immunization to help protect newborns from RSV seasonally where the vaccine should be administered from September through January in most of the continental United States. Also in August 2023, Pfizer announced that the European Medicines Agency (EMA) granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants. The vaccine has also received approvals from la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) of Argentina in September 2023; the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom in November 2023; Health Canada in January 2024; the Pharmaceutical Administration Bureau of Macau in February 2024; the Ministry of Health, Labour, and Welfare of Japan for maternal immunization to help protect infants in January 2024 and for older adults in March 2024; and the Therapeutic Goods Administration of Australia in March 2024 for older adults. In addition to MONeT, Pfizer has initiated a clinical trial evaluating ABRYSVO in children ages two to less than 18 years who are at higher risk for RSV disease.18 INDICATIONS FOR ABRYSVO ABRYSVO™ is a vaccine indicated in the US for: the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age IMPORTANT SAFETY INFORMATION FOR ABRYSVO ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO Vaccination with ABRYSVO may not protect all people In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo) View the full ABRYSVO Prescribing Information. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of April 9, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about ABRYSVO, including its potential benefits, plans to submit MONeT data to regulatory authorities, a potential new indication for ABRYSVO and clinical trials initiated for ABRYSVO in other populations, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in particular jurisdictions for ABRYSVO for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO for any such indications will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Category: Vaccines _____________________________ 1 Weycker, D., Averin, A., Houde, L. et al. Rates of Lower Respiratory Tract Illness in US Adults by Age and Comorbidity Profile. Infect Dis Ther 2024;13: 207–220. doi: 10.1007/s40121-023-00904-z. Epub 2024 Jan 18. PMID: 38236516; PMCID: PMC10828164. 2 Centers for Disease Control and Prevention. “Epidemiology of Respiratory Syncytial Virus Hospitalizations in Adults — RSV-NET.” . Presented October 25, 2023. Last Accessed April 2024. 3 Walsh EE, Gonzalo PM, et al. “Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults.” The New England Journal of Medicine. April 20, 2023. . 4 Fink D. Immunobridging to Evaluate Vaccines. . Published June 2021, Last Accessed April 2024. 5 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). . Updated December 18, 2020. 6 Centers for Disease Control and Prevention. RSV Transmission. . Updated December 18, 2020. 7 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. . 8 Centers for Disease Control and Prevention. RSV in Infants and Young Children. . 9 Centers for Disease Control and Prevention. RSV Surveillance & Research. . 10 Widmer K, Zhu Y, Williams JV, et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. J Infect Dis. 2012; 206(1):56-62. 11 Branche AR, Saiman L, Walsh EE, et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020. CID. 2022;74(6):1004-1011. 12 McLaughlin JM, Khan F, Begier E, et al. Rates of Medically Attended RSV among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022; 9(7): ofac300. 13 Zheng Z, Warren JL, Shapiro ED, et al. Estimated Incidence of Respiratory Hospitalizations Attributable to RSV Infections across Age and Socioeconomic Groups. Pneumonia. 2022;14(1):6. 14 Centers for Disease Control and Prevention. October 2022 ACIP Meeting Slides. ACIP Adult RSV Work Group Considerations. Available at: . 15 Thompson WW, Shay DK, Weintraub E, et al. Mortality Associated with Influenza and Respiratory Syncytial Virus in the United States. JAMA. 2003; 289(2): 179.186. 16 Matias G, Taylor R, Haguinet F, et al. Estimates of Mortality Attributable to Influenza and RSV in the United States during 1997–2009 by Influenza Type or Subtype, Age, Cause of Death, and Risk Status. Influenza Other Respir Viruses. 2014; 8(5):507-15. 17 Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 1999-2018.JAMA Network Open. 2022 Feb 1;5(2):e220527 18 Pfizer Second-Quarter 2023 Earnings Teleconference Presentation, August 1, 2023, page, 24, .